TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
               DRAFT TANZANIA STANDARD  
 
Hospital base d intravenous fluids -Good manufacturing practice ( GMP) - 
Requirement for regulatory purposes  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TANZANIA BUREAU OF STANDARDS  
 
 
TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
0 FOREWORD   
This Draft Tanzania  Standard is being prepared by the Pharmaceuticals Technical Committee, under the 
supervision of Chemicals Divisional Standards Committee and it is in accordance with the procedures of the 
Bureau.  
 
In the preparation of this Draft Tanzania Standard assista nce was drawn from :  
 
        Rwandan  National Standard RS 74 -1:2017 Quality assurance of pharmaceuticals — Good  
        manufacturing practices and inspections, Part 1: Main principles for pharmaceutical products  published  
        by Rwanda Standards Boar d (RSB)   
        Guidelines for production of extemporaneous formulations and Hospital based sterile preparations by  
        TMDA. 
 
For the purpose of deciding whether a particular requirement of this draft Tanzania Standard is complied with, 
the final va lue observed or calculated, expressing the result of a test or analysis, shall be rounded off in 
accordance with TZS 4.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
 
 
 
 
 
Introduction  
 
Good manufacturing practice  (GMP)  is that part of quality assurance whic h ensures that products are 
consistently produced and controlled to the quality standards appropriate to their intended use and as required 
by the  recommended minimum requirements for hospital based intravenous fluids . GMP rules are directed 
primarily to d iminishing the risks, inherent in production  of hospital based intravenous fluids , which cannot be 
prevented completely through the testing of final products. Such risks are essentially of two types: cross -
contamination (in particular by unexpected contam inants) and mix -ups (confusion) caused by false labels 
being put on containers.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
  
 
 
 
 
 
 
Hospital based intravenous fluids -Good manufacturing practice (GMP) -Requirement 
for regulatory purposes  
 
 
1.Scope  
 
This Tanzani a Standard shall be used to justify good manufacturing practices (GMP) status for Intravenous 
fluids produced in hospital Infusion Units.  
 
NOTE 1  The standard is applicable to all small -scale operations for the production of infusion  in their finished dosa ge 
forms, including small -scale processes in hospitals.  
NOTE 2  The good practices outlined below are to be considered general guides, and they may be adapted to meet 
individual needs  on risk bases .  The equivalence of alternative approaches to quality assu rance should be validated.  Non-
proprietary names for pharmaceutical substances designated by WHO should be used when available, together with other 
designated names.  
2.0 Normative references  
The following referenced documents are indispensable for the appl ication of this document. For dated 
references, only the edition cited applies. For undated references, the latest edition of the referenced 
document (including any amendments) applies . 
TZS 773:2017 Labelling and marking of pharmaceuticals - specification  
Terms and definitions  
For the purposes of this standard, the following terms and definitions apply.  
3.1 
active pharmaceutical ingredient  
a substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a 
pharmacologica lly active compound (ingredient)  
 
3.2 
airlock   
an enclosed space with two or more doors, which is interposed between two or more rooms, e.g. of differing 
classes of cleanliness, for the purpose of controlling the airflow between those rooms when they need  to be 
entered, and is designed for and used by either people or goods  and/or equipment’s . 
3.3 
authorized person   
a person responsible for the release of batches of finished product for distribution   
3.4 
batch (or lot)   
a defined quantity of starting mat erial, packaging material, or product processed in a single process or series 
of processes so that it can be expected to be homogeneous; in the case of continuous manufacture, the batch 
shall correspond to a defined fraction of the production, characterize d by its intended homogeneity, and it may 
sometimes be necessary to divide a batch into a number of sub -batches, which are later brought together to 
form a final homogeneous batch.  TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 3.5 
batch number (or lot number)   
a distinctive combination of numbers and /or letters which specifically identifies a batch and is found on the 
labels, the batch records, the certificates of analysis, etc.  
3.6 
bulk product   
any product that has completed all processing stages up to, but not including, final packaging  
3.7 
calibr ation   
the set of operations that establish, under specified conditions, the relationship between values indicated by 
an instrument or system for measuring (especially weighing), recording and controlling, or the values 
represented by a material measure, and the corresponding known values of a reference standard; limits for 
acceptance of the results of measuring shall be established  
3.8 
clean area   
an area with defined environmental control of particulate and microbial contamination constructed and used i n 
such a way as to reduce the introduction, generation and retention of contaminants within the area . 
3.9 
critical Process  
a process that may cause variation in the quality of the pharmaceutical product  
3.10 
cross -contamination   
contamination of a starti ng material, intermediate product, or finished product with another starting material or 
product during production  
 
3.11 
finished product   
a product that has undergone all stages of production, including packaging in its final container and labelling  
3.12 
in-process control   
checks that are performed during production in order to monitor and, if necessary, to adjust the process to 
ensure that the product conforms to its specifications; the control of the environment or equipment may also 
be regarded as a part of in -process control  
3.13 
intermediate product  
partly processed material that shall undergo further manufacturing steps before it becomes a bulk product  
3.14 
large -volume parenterals   
sterile solutions intended for parenteral application with a vol ume of 100 mL or more in one container of the 
finished dosage form.  
3.15   
manufacturer   
a hospital -based  facility  that carries out at least one step of production of infusion products  
3.16   
master formula  
a document or set of documents specifying the s tarting materials with their quantities and the packaging 
materials, together with a description of the procedures and precautions required to produce a specified 
quantity of a finished product as well as the processing instructions, including the in -proce ss controls  
 
3.17 
production   
all operations involved in the preparation of a pharmaceutical product, from receipt of materials, through 
processing and packaging, to completion of the finished product  TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 
 3.18 
quality assurance   
part of quality management fo cused on providing confidence that quality requirements will be fulfilled  
 
 3.19 
quality control   
part of quality management focused on fulfilling quality requirements  
 
3.20 
quarantine   
the status of starting or packaging materials intermediates, or bulk  or finished products isolated physically or 
by other effective means while a decision is awaited on their release, rejection, or reprocessing  
 
3.21 
reprocessing   
the reworking of all or part of a batch of product of an unacceptable quality from a defined  stage of production 
so that its quality may be rendered acceptable by one or more additional operations  
 
3.22 
returned product   
finished product sent back to the manufacturer  
 
3.23 
specification   
a document describing the detailed requirements with whic h the products or materials used or obtained during 
manufacture have to conform specifications serve as a basis for quality evaluation  
 
3.24 
standard operating procedure (SOP)   
an authorized written procedure giving instructions for performing operations not necessarily specific to a 
given product or material but of a more general nature (e.g., equipment operation, maintenance and cleaning, 
validation, cleaning of premises and environmental control, sampling and inspection).  Certain SOPs may be 
used to su pplement product -specific master and batch production documentation.  
 
3.25 
starting material   
any substance of a defined quality used in the production of a  hospital -based  infusion , but excluding 
packaging materials  
 
3.26 
system   
a regulated pattern of i nteracting activities and techniques that are united to form an organized whole  
 
3.27 
validation   
the documented act of proving that any procedure, process, equipment, material, activity or system actually 
leads to the expected results  
 
3.28 
Pharmacovigil ance 
science and activities relating to the detection, assessment, understanding and prevention of adverse effects 
or any other drug -related problem.  
 
 
 
 TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 4. Requirements  
 
4.1 General GMP requirements   
 
4.1.1 All production processes shall be  clearly defin ed, systematically reviewed in the light of experience, 
and shown to be capable of consistently manufacturing IV fluids  in hospital -based  setup  of the required 
quality that comply with their specifications;  
4.1.2 Critica l steps of production  processes and any significant changes made to the processes shall be 
validated  all necessary facilities shall be  provided, including:  
a) Appropriately qualified and trained personnel;  
b) Adequate  premises and space  
c) Adequate separation between processes  
d) Suitable  equipment and services  
e) Correct  materials, containers and labels  
f) Approved  procedures and instructions  
g) Suitable  storage and transport . 
4.1.3 Instructions and procedures shall be  written in clear and unambiguous language, specifically 
applicable to the facilities provided;  
4.1.4 Operators  shall be  trained to carry out procedures correctly;  
4.1.5 Records shall be  made (manually and/or by recording instruments) during  production  to show that 
all the steps required by the defined procedures and instructions have in fact been t aken and that the 
quantity and quality of the product are as expected; any significant deviations are fully recorded and 
investigated;  
4.1.6 Records  covering  production  and distribution, which enable the complete history of a batch to be 
traced shall be  retained in a comprehensible and accessible form;  
4.1.7 A system shall be available  to recall any batch of product from supply;  
4.1.8 Complaints  about supplied  products shall be  examined, the causes of quality defects investigated, 
and appropriate measures t aken in respect of the defective products and to prevent recurrence.  
4.1.9 Rodenticides, insecticides, fumigating agents and sanitizing materials shall not be permitted to 
contaminate equipment, starting materials, packaging materials, in -process materials , or finished  
products.  
 
5. Specific GMP requirements  
 
5.1 Master formulae  
5.1.1 A formally authorized master formula shall exist for each product  with its standard.  
5.1.2 The master formula shall include:  
a) The name of the product, with a product reference monograph  relating to its specification;  
b) Strength  of the product, and batch size;  
c) A list of all starting materials to be used (if applicable, with the International Non-proprietary  
Names), with the amount of each, described using the designated name and a reference that is 
unique to that material  
d) Any special precautions to be observed.  
 
5.2 Equipment  
 
5.2.1 Equipment shall be located, designed, constructed, adapted and maintained to suit the operations 
to be carried out.  The layout and design of equipment shall aim to minimize the risk of errors and permit 
effective cleaning and maintenance in order to avoid cross -contamination, build -up of dust or dirt, and in 
general, any adverse effect on the quality of products.  
5.2.2 Equipment shall be installed in suc h a way as to minimize any risk of error or of contamination.  
5.2.3 Fixed pipe -work shall be clearly labeled to indicate the contents and where applicable, the direction 
of flow.  
5.2.4 All service piping and devices shall be adequately marked and special a ttention paid to the 
provision of non -interchangeable connections or adaptors for dangerous gases and liquids.  TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 5.2.5 Balances and other measuring equipment of an appropriate range and precision shall be available 
for production and control operations and s hall be calibrated on a scheduled basis.  
5.2.6 Production equipment shall be designed, located and maintained to serve its intended purpose.  
5.2.7 Production equipment shall be designed so that it can be easily and thoroughly cleaned on a 
scheduled basis.  
5.2.8 Control -laboratory equipment and instruments shall be suited to the testing procedures undertaken.  
5.2.9 Washing and cleaning equipment shall be chosen and used so as not to be a source of 
contamination.  
5.2.10 Production equipment shall not present any hazard to the products.  The parts of the production 
equipment that come into contact with the product shall not be reactive, additive, or absorptive to an 
extent that would affect the quality of the product.  
5.2.11 Defective equipment shall, if possib le, be removed from production and quality control areas, or at 
least be clearly labeled as defective.  
 
5.3 Standard Operating Procedures (SOPs) and Records  
5.3.1 There shall be standard operating procedures and records for the receipt of each delivery of starting 
material and primary and printed packaging material.  
5.3.2 The records of the receipts shall include:  
a) The name of the material on the delivery note and the containers;  
b) The “in-house” name and/or code of material if different from (a);  
c) The date of receipt;  
d) The supplier’s name and, if possible, manufacturer’s name;  
e) The manufacturer’s batch or reference number;  
f) The total quantity, and number of containers received;  
g) The batch number assigned after receipt; and  
h) Any relevant comment (e.g., state of the c ontainers).  
5.3.3 There shall be standard operating procedures for the internal labeling, quarantine, and storage of 
starting materials, packaging materials and other materials, as appropriate.  
5.3.4 Standard operating procedures shall be available for eac h instrument and piece of equipment and 
placed in close proximity to the equipment.  
5.3.5 There shall be standard operating procedures for sampling, which specify the person(s) authorized 
to take samples.  
5.3.6 The sampling instructions shall include:  
a) The method of sampling and the sampling plan;  
b) The equipment to be used;  
c) Any precautions to be observed to avoid contamination of the material or any deterioration in its 
quality ; 
d) The amount(s) of sample(s) to be taken;  
e) Instructions  for any required subdivision  of the sample;  
f) The type of sample container(s) to be used, and whether they are for aseptic sampling or for 
normal sampling;  
g) Any specific precautions to be observed, especially in regard to the sampling of sterile or noxious 
material.  
5.3.7 There shall be  a standard operating procedure describing the details of the batch (lot) numbering 
system, with the objective of ensuring that each batch of intermediate, bulk, or finished product is 
identified with a specific batch number.  
5.3.8 The standard operating p rocedures for batch numbering that are applied to the processing stage 
and to the respective packaging stage shall be related to each other.  
5.3.9 The standard operating procedure for batch numbering shall assure that the same batch numbers 
will not be rep eatedly used, this applies also to reprocessing.  
5.3.10 Batch number allocation shall be immediately recorded, e.g. in a logbook.  The record shall include 
date of allocation, product identity, and size of batch.  
5.3.11 There shall be written procedures fo r testing materials and products, describing the methods and 
equipment to be used.  The tests performed shall be recorded.  TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
 5.3.12 Records shall be maintained of the distribution of each batch of a product in order to facilitate the 
recall of the batch if n ecessary.  
5.3.13 Standard operating procedures and associated records of actions taken or, where appropriate, 
conclusions reached shall be available for:  
a) Equipment  assembly and validation;  
b) Analytical  apparatus and calibration;  
c) Maintenance , cleaning and san itization;  
d) Personnel  matters including qualification, training, clothing and hygiene;  
e) Environmenta l monitoring;  
f) Pest control;  
g) Complaints;  
h) Recalls ; and  
i) Returns.  
5.3.14 Logbooks shall be kept with major and critical equipment and shall record, as appropriate , any 
validations, calibrations, maintenance, cleaning, or repair operations, including dates and the identity of 
the people who carried these operations out.  
5.3.15 There shall be written procedures assigning responsibility for sanitation and describing i n sufficient 
detail the cleaning schedules, methods, equipment, and materials to be used and facilities to be cleaned.  
Such written procedures shall be followed.  
 
5.3.16 Physical separation between processe s 
There shall be a clear separation of all activi ties within the Hospital infusion Unit.  
 
5.4 Quality assurance  
The manufacturer shall assume responsibility for the quality of the hospital based IV fluids to ensure that 
they are fit for their intended use, comply with the requirements and do not place p atients at risk due to 
inadequate safety, quality, or efficacy.  The attainment of this quality objective is the responsibility of 
senior management and requires the participation and commitment of staff in many different departments 
and at all levels with in the hospital system .  To achieve the quality objective reliably there shall be a 
comprehensively designed and correctly implemented system of quality assurance incorporating GMP 
and quality control.  It shall be fully documented and its effectiveness mo nitored.  All parts of the quality 
assurance system shall be adequately staffed with competent personnel and shall have suitable and 
sufficient premises, equipment and facilities.  
 
5.5 Quality control  
Assessment of finished products shall embrace all relev ant factors, including the production conditions, 
the manufacturing (including packaging) documentation and an examination of the finished product . 
 
5.6 Sanitation and hygiene  
A high level of sanitation and hygiene shall be practiced in every aspect of the  manufacture of hospital -
based  infusion products .  The scope of sanitation and hygiene covers personnel, premises, equipment 
and apparatus, production materials and containers, products for cleaning and disinfection, and anything 
that could become a source  of contamination to the product. Potential sources of contamination shall be 
eliminated through an integrated comprehensive program of sanitation and hygiene.  
   
5.7 Waste materials  
5.7.1Provision shall be made for the proper and safe storage of waste mat erials awaiting disposal.   
5.7.2 Toxic substances and flammable materials shall be stored in suitably designed  separate, enclosed 
cupboards as required by national legislation.  
5.7.3Waste material shall not be allowed to accumulate.  It shall be collected  in suitable receptacles for 
removal to collection points outside the buildings, and disposed of safely and in a sanitary manner at 
regular and frequent intervals.  
 TBS/CDC 16( 5438 ) P3  
 ©TBS 20 20 – All rights reserved                                                                                   First Edition 2020  
  
 
 
5.8 Product recall  
There shall be a system to recall from the wards , promptly and effect ively, products known or suspected 
to be defective.  
 
5.9 Premises  
Premises shall be located, designed, constructed, adapted and maintained to suit the operations to be 
carried out.  Their layout and design shall aim to minimize the risk of errors and permi t effective cleaning 
and maintenance in order to avoid cross -contamination, build -up of dust or dirt and in general, any 
adverse effect on the quality of products.  
 
5.10 Storage areas  
Storage areas shall be of sufficient capacity to allow orderly storage o f the various categories of materials 
and products . 
 
5.11 Documentation  
Good documentation is an essential part of the quality assurance system and as such, shall be related to 
all aspects of GMP.  Its aims are to define the specifications for all material s and methods of manufacture 
and control, to ensure that all personnel concerned with manufacture know what to do and when to do it, 
to ensure that authorized persons have all the information necessary to decide whether or not to release 
a batch of infusio n for use, and to provide an audit trail that will permit investigation of the history of any 
suspected defective batch.  The design and use of documents depend upon the  infusion unit within the  
health facility . 
   
5.12 Pharmacovigilance  
Pharmacovigilance (PV) is  very important in patients’  side who use sterilized hospital based intravenous 
fluids. The  aims of PV are to enhance patient care and patient safety in relation to the use of medicines; 
and to support public health programs  by providing reliable, b alanced information for the effective 
assessment of the risk -benefit profile of medicines. It  will be the responsibility of the hospital with infusion 
unit to establish documentation and proper follow up of adverse drug reaction pertaining to infusion 
produced in their facility. Reports  shall be submitted to regulatory authority .  
 
6. Labelling and Marking  
 
Labelling and marking shall be done in accordance with TZS 773